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HIPAA Compliance: What Every Developer Should Know
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morganb01
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morganb01,
User Rank: Apprentice
7/16/2014 | 8:33:12 PM
Re: Oversight Committee?
Hi Alison,

It certainly should make for an interesting next 24 months or so. The FDA is already overwhelmed with all of the new mobile health apps, and can't keep up with the pace of innovation. In fact, the FDA has only evaluated about 100 apps, which is a fraction of the available health and fitness apps in the appstores. Of course, they won't evaluate them all—just ones that could cross into medical device territory. (source: http://www.pbs.org/newshour/rundown/fda-regulation-unable-keep-pace-new-mobile-health-apps/)

The Office of Civil Rights, which manages HIPAA complaints has also seen a huge spike in privacy complaint activity. A large portion of those complaints are referred to the state level, and state Attorney's General offices are handling more complaints at the state level.

The overlapping responsibilities between FDA, HIPAA regulation and state/federal oversight will certainly evolve. The HIPAA Omnibus Final Rule passed last year ammended HIPAA to require all Business Associates be compliant, and I'm sure we'll continue to see more evolution in response to the changing marketplace. 

There is no question however that these entities will continue to lag the market, and so consumers will want to take a close look at the apps they use and trust with their personal health data. 
Alison_Diana
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Alison_Diana,
User Rank: Author
7/11/2014 | 2:08:19 PM
Oversight Committee?
As the FDA scrutinizes medical devices to see whether they should fall under its sphere of control, I wonder whether we'll see government expand what is covered under HIPAA now more states (such as Florida) are enacting their own laws around privacy, including personal health information?


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